What is the appropriate dosing for Atomoxetine (Strattera)?

From the Guidelines

Strattera dosing should start at 40 mg po daily, with titration every 7-14 days to 60 then 80 mg/d, and a maximum recommended dose of the lesser of 1.4 mg/kg/d or 100 mg/d. This dosing strategy is based on the most recent and highest quality study available, which was published in 2024 in the American Journal of Obstetrics and Gynecology 1. The study provides guidance on the treatment of attention-deficit/hyperactivity disorder (ADHD) with nonstimulants, including atomoxetine (Strattera). Key points to consider when dosing Strattera include:

• Starting dose: 40 mg po daily
• Titration: every 7-14 days to 60 then 80 mg/d
• Maximum recommended dose: the lesser of 1.4 mg/kg/d or 100 mg/d
• Atomoxetine does not seem to be associated with major congenital malformations or other significant adverse obstetrical or developmental outcomes, although data are limited 1. When prescribing Strattera, it is essential to monitor patients for potential side effects and adjust the dose accordingly to minimize adverse effects while maximizing therapeutic benefits.

From the FDA Drug Label

Dosing of children and adolescents up to 70 kg body weight - Atomoxetine capsules should be initiated at a total daily dose of approximately 0.5 mg/kg and increased after a minimum of 3 days to a target total daily dose of approximately 1.2 mg/kg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. Dosing of children and adolescents over 70 kg body weight and adults - Atomoxetine capsules should be initiated at a total daily dose of 40 mg and increased after a minimum of 3 days to a target total daily dose of approximately 80 mg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening The recommended dosing for Strattera (atomoxetine) is as follows:

• For children and adolescents up to 70 kg:
  • Initial dose: 0.5 mg/kg/day
  • Target dose: 1.2 mg/kg/day
• For children and adolescents over 70 kg and adults:
  • Initial dose: 40 mg/day
  • Target dose: 80 mg/day The maximum recommended dose is 100 mg/day 2

From the Research

Strattera Dosing

• Strattera (atomoxetine) is a selective norepinephrine reuptake inhibitor that can be administered either as a single daily dose or split into two evenly divided doses 3, 4.
• The dosing of Strattera may vary depending on the patient's response to the medication and their individual needs.
• Studies have shown that Strattera is effective in the treatment of attention-deficit/hyperactivity disorder (ADHD) in both children and adults, with improvements in ADHD symptoms and health-related quality of life 3, 4.

Administration and Pharmacokinetics

• Strattera is rapidly absorbed and demonstrates dose-proportional increases in plasma exposure 3.
• It undergoes extensive biotransformation, which is affected by poor metabolism by cytochrome P450 (CYP) 2D6 in a small percentage of the population 3.
• Patients with hepatic insufficiency show an increase in Strattera exposure, and CYP2D6 inhibitors, such as paroxetine, are associated with changes in Strattera pharmacokinetics similar to those observed among poor CYP2D6 metabolizers 3.

Efficacy and Safety

• Strattera has been shown to be effective in the treatment of ADHD in both children and adults, with significant improvements in ADHD symptoms and health-related quality of life 3, 4.
• Common adverse events associated with Strattera include headache, abdominal pain, decreased appetite, vomiting, somnolence, and nausea 3, 4.
• Strattera is generally well tolerated, with a low incidence of serious adverse events and discontinuation-emergent adverse events 3, 4.